Posted on 08/21/2004 10:52:43 AM PDT by workerbee
PALO ALTO, Calif. - In an Internet message to family and friends on July 12, Leigh Bills described her 3-month-old son, Miles Coulson: "He is very pale, almost gray and his extremities are cold. We sit and hold his little hands but as soon as we let go they get so cold."
"All the doctors agree there is no time to waste," she wrote.
Miles needed a heart transplant. Though he was born healthy to Ms. Bills and her husband, Adrian Coulson, his heart began to fail when he was only a few weeks old, possibly because of a viral illness. By late June, he was on the transplant list.
But donor hearts from infants are so scarce that doctors feared Miles would not live long enough to receive one. Older children and adults waiting for transplants can be kept alive by mechanical pumps implanted in the chest, but none of the pumps approved in the United States is small enough for an infant. There has been little incentive for companies to develop pumps for babies, experts say, because the market is not large enough.
In a desperate move to save Miles, his doctors sought a device they had never tried before: a miniaturized pump called the Berlin Heart, which has been widely used in Europe but not approved in this country.
"I don't think there was any other prospect for keeping him alive," said Dr. David Rosenthal, director of the pediatric heart failure program at Lucile Packard Children's Hospital, at Stanford University.
On July 8 and 9, Dr. Rosenthal asked Stanford's ethics panel and the Food and Drug Administration to let the hospital import the Berlin Heart for Miles. Both agreed, within hours. The device was flown to the United States from Germany on July 12, accompanied by Dr. Peter Göttel, a heart surgeon who works for the pump's manufacturer in the city for which the heart was named. Surgery to connect Miles to the device was scheduled for the next morning.
The history of Miles Coulson's illness is a reminder that the boundary between health and sickness is fragile, and a family's fortunes can turn swiftly from joy to sadness. It is also a story of parents pinning their hopes on a piece of medical technology, wondering whether it will save their child's life or merely prolong his suffering.
The number of infants who might be saved by pumps like the Berlin Heart is not known, but is probably in the hundreds, said Dr. Tracey Hoke, a pediatric cardiologist and medical officer at the National Heart, Lung and Blood Institute.
"It's definitely an orphan product," Dr. Hoke said. "It's a tiny market, but high profile. These are people's babies. It won't help a lot of people, but it will help a few people a lot."
She said that the institute, hoping to fill the gap in the United States, awarded five contracts in April, with a total value of $22.4 million, to companies and universities to develop heart-assisting devices for infants. But it will take five years before any is ready even for testing in humans. And Dr. Hoke warned that even if more pumps did become available they would not solve the organ shortage and some infants might die anyway. In those cases the pump may just give families more time, she said, "to cope and lose their child."
Dr. Göttel said that the Berlin Heart was made in a range of sizes, and since 1989 had been used in more than 950 people, including about 50 babies in Europe. The longest an infant has survived on the pump is three months, he said.
Over all, Dr. Göttel said, about two-thirds of patients who receive the pump survive, going on either to recover or receive a transplant.
An F.D.A. Application
He said the company is preparing an application to the Food and Drug Administration for a "humanitarian device exemption," which is not a full approval, but a special arrangement for devices for which there is no alternative. The exemption would allow hospitals to keep the heart pump in stock - which they are not permitted to do now - and use it when needed without having to request special permission and import it every time.
Three other children in the United States have been treated with Berlin Hearts. Two received transplants and a third recovered, so the pump was removed.
Prayers for this little baby, for his parents, and the fine folks struggling to keep him alive.
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